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Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions InvolvingLarge Side Branches: Outcomes From the Tryton Confirmatory Study

Généreux, Philippe; Kumsars, Indulis; Schneider, Joel E.; Lesiak, Maciej; Redfors, Björn; Cornelis, Kristoff; Selmon, Matthew R.; Dens, Jo; Hoye, Angela; Metzger, D. Christopher; Muyldermans, Luc; Slagboom, Ton; Francese, Dominic P.; Ayele, Girma Minalu; Laak, Linda L.; Bartorelli, Antonio L.; Cutlip, Donald E.; Kaplan, Aaron V.; Leon, Martin B.

Authors

Philippe Généreux

Indulis Kumsars

Joel E. Schneider

Maciej Lesiak

Björn Redfors

Kristoff Cornelis

Matthew R. Selmon

Jo Dens

D. Christopher Metzger

Luc Muyldermans

Ton Slagboom

Dominic P. Francese

Girma Minalu Ayele

Linda L. Laak

Antonio L. Bartorelli

Donald E. Cutlip

Aaron V. Kaplan

Martin B. Leon



Abstract

Objectives: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs ( < 2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled.

Methods
The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT.

Results
Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint.

Conclusions
The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

Citation

Généreux, P., Kumsars, I., Schneider, J. E., Lesiak, M., Redfors, B., Cornelis, K., …Leon, M. B. (2016). Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions InvolvingLarge Side Branches: Outcomes From the Tryton Confirmatory Study. JACC: Cardiovascular Interventions, 9(13), 1338-1346. https://doi.org/10.1016/j.jcin.2016.03.042

Journal Article Type Article
Acceptance Date Mar 24, 2016
Online Publication Date Jul 4, 2016
Publication Date Jul 11, 2016
Deposit Date Apr 9, 2019
Journal JACC: Cardiovascular Interventions
Print ISSN 1936-8798
Electronic ISSN 1876-7605
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 9
Issue 13
Pages 1338-1346
DOI https://doi.org/10.1016/j.jcin.2016.03.042
Keywords Bifurcation; PCI; Side branch; Stent; Tryton dedicated bifurcation stent
Public URL https://hull-repository.worktribe.com/output/1567794
Publisher URL https://www.sciencedirect.com/science/article/pii/S1936879816304903?via%3Dihub
Additional Information This article is maintained by: Elsevier; Article Title: Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches; Journal Title: JACC: Cardiovascular Interventions; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.jcin.2016.03.042; Content Type: article; Copyright: © 2016 by the American College of Cardiology Foundation. Published by Elsevier